Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Guidance for Industry; Availability, 35366-35367 [2015-15076]

Download as PDF 35366 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–643 Hospice Survey and Deficiencies Report Form and Supporting Regulations asabaliauskas on DSK5VPTVN1PROD with NOTICES Information Collection 1. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Hospice Survey and Deficiencies Report Form and Supporting Regulations; Use: We use the information collected as the basis for certification decisions for hospices that wish to obtain or retain participation in the Medicare and Medicaid programs. The information is used by CMS regional offices, which have the delegated authority to certify Medicare 19:33 Jun 18, 2015 Jkt 235001 Dated: June 16, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015–15126 Filed 6–18–15; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. VerDate Sep<11>2014 facilities for participation, and by State Medicaid agencies, which have comparable authority under Medicaid. The information on the Hospice Survey and Deficiencies Report Form is coded for entry into the OSCAR system. The data is analyzed by the CMS regional offices and by the CMS central office components for program evaluation and monitoring purposes. The information is also available to the public upon request. Form Number: CMS–643 (OMB control number: 0938–0379); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 3,976; Total Annual Responses: 1,325; Total Annual Hours: 1,325. (For policy questions regarding this collection contact Annette Snyder at 410–786–0807.) Food and Drug Administration [Docket No. FDA–2013–N–1434] Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.’’ This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets and capsules intended to be swallowed intact. FDA is concerned that differences in these physical characteristics between generic drugs and the originator drug could affect patient outcomes. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– SUMMARY: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Debra Catterson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 240–402–3861; or Vilayat Sayeed, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 240–402–9077. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.’’ FDA is concerned that the differences in size, shape, and other physical characteristics between a generic drug and the originator drug may affect patient compliance and acceptability of medication regimens or could lead to medication errors. For example, studies show that tablet size and shape can affect ease of swallowing; generic tablets that are significantly larger than their corresponding reference drug product may be more difficult to swallow, leading to potential adverse events as well as noncompliance with treatment regimens. FDA is recommending that generic manufacturers consider the size, shape, and other physical characteristics of the originator drug when developing a generic version. In the Federal Register of December 10, 2013 (78 FR 74154), this guidance was published as a draft guidance. We have carefully reviewed and considered the comments that were received on the draft guidance and have made editorial changes primarily for clarification. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on the size, shape, and other physical attributes of generic tablets and capsules. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. E:\FR\FM\19JNN1.SGM 19JNN1 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection of information requested in the guidance is covered under FDA regulations at 21 CFR part 314 and approved under OMB control number 0910–0001. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: June 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–15076 Filed 6–18–15; 8:45 am] BILLING CODE 4164–01–P 35367 Food and Drug Administration Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015–2025) [Docket No. FDA–2014–N–2033] (OMB Control Number 0910-NEW) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 20, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–NEW and title Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: From 1998–2008, FDA’s National Retail Food Team conducted a study to measure trends in the occurrence of foodborne illness risk factors, preparation practices, and employee behaviors most commonly reported to the Centers for Disease Control and Prevention as contributing factors to foodborne illness outbreaks at the retail level. Specifically, data was collected by FDA Specialists in retail and foodservice establishments at 5-year intervals (1998, 2003, and 2008) in order to observe and document trends in the occurrence of the following foodborne illness risk factors: • Food from Unsafe Sources, • Poor Personal Hygiene, • Inadequate Cooking, • Improper Holding/Time and Temperature and • Contaminated Equipment/CrossContamination. FDA developed reports summarizing the findings for each of the three data collection periods (1998, 2003, and 2008) (Refs. 1–3). Data from all three data collection periods were analyzed to detect trends in improvement or regression over time and to determine whether progress had been made toward the goal of reducing the occurrence of foodborne illness risk factors in selected retail and foodservice facility types (Ref. 4). Using this 10-year survey as a foundation, in 2013–2014, FDA initiated a new study in full service and fast food restaurants. This study will span 10 years with additional data collections planned for 2017–2018 and 2021–2022. FDA is proposing to collect data in select institutional foodservice and retail food store facility types in 2015– 2016. This proposed study will also span 10 years with additional data collections planned for 2019–2020 and 2023–2024. asabaliauskas on DSK5VPTVN1PROD with NOTICES TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY Facility type Description Healthcare Facilities ........................ Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible populations as defined as follows: • Hospitals—A foodservice operation that provides for the nutritional needs of inpatients by preparing meals and transporting them to the patient’s room and/or serving meals in a cafeteria setting (meals in the cafeteria may also be served to hospital staff and visitors). • Long-term care facilities—A foodservice operation that prepares meals for the residents in a group care living setting such as nursing homes and assisted living facilities. VerDate Sep<11>2014 19:33 Jun 18, 2015 Jkt 235001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1

Agencies

[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Pages 35366-35367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15076]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1434]


Size, Shape, and Other Physical Attributes of Generic Tablets and 
Capsules; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Size, Shape, and 
Other Physical Attributes of Generic Tablets and Capsules.'' This 
guidance discusses FDA recommendations for the size, shape, and other 
physical attributes of generic tablets and capsules intended to be 
swallowed intact. FDA is concerned that differences in these physical 
characteristics between generic drugs and the originator drug could 
affect patient outcomes.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Debra Catterson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-3861; or Vilayat 
Sayeed, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
240-402-9077.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Size, Shape, and Other Physical Attributes of Generic 
Tablets and Capsules.'' FDA is concerned that the differences in size, 
shape, and other physical characteristics between a generic drug and 
the originator drug may affect patient compliance and acceptability of 
medication regimens or could lead to medication errors. For example, 
studies show that tablet size and shape can affect ease of swallowing; 
generic tablets that are significantly larger than their corresponding 
reference drug product may be more difficult to swallow, leading to 
potential adverse events as well as noncompliance with treatment 
regimens. FDA is recommending that generic manufacturers consider the 
size, shape, and other physical characteristics of the originator drug 
when developing a generic version.
    In the Federal Register of December 10, 2013 (78 FR 74154), this 
guidance was published as a draft guidance. We have carefully reviewed 
and considered the comments that were received on the draft guidance 
and have made editorial changes primarily for clarification.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on the size, shape, and other physical 
attributes of generic tablets and capsules. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

[[Page 35367]]

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information requested in the guidance is covered under 
FDA regulations at 21 CFR part 314 and approved under OMB control 
number 0910-0001.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: June 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15076 Filed 6-18-15; 8:45 am]
BILLING CODE 4164-01-P
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